The ATLAST Long-Term Study

Obstructive Sleep Apnea (OSA) Clinical Trial

Official title:

The ATLAST Long-Term Study. A Multicenter, Prospective, Long-Term Study of the Attune Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476917
• Other study ID #: 11449
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 16, 2011
• Last updated: November 5, 2012
• Start date: November 2011
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: ApniCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The Study is a multi-center, prospective, open label, single-arm, three-month, long-term study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea (OSA). The objective of the study is to monitor long-term use of the Attune Sleep Apnea System.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subject participated in the ATLAST Study, and completed the 28-day take-home period

• Subject understands the Study protocol and is willing and able to comply with Study requirements and sign the informed consent form.

• The study physician and investigator believe that study participation is appropriate for the subject.

• Subject has at least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower).

Exclusion Criteria:

• Female subjects who are pregnant or intend to become pregnant during the study period.

• Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.

• Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the Attune Sleep Apnea System

• History of any OSA surgical treatment

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Attune Sleep Apnea System
Observation of Attune Sleep Apnea System for use during sleep.

Locations

Country	Name	City	State
United States	Sleep Disorders Center of Georgia	Atlanta	Georgia
United States	Penninsula Sleep Center (PSC)	Burlingame	California
United States	SleepMed	Columbia	South Carolina
United States	Sleep Medicine Associates of Texas (SMAT)	Dallas	Texas
United States	SRI International	Menlo Park	California
United States	REM Medical	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
ApniCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of hours per night of device use over a 3-month period	Nightly use will be monitored over a 3-month take-home period.	Each night's use	No